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{
"id": 1104086,
"url": "https://info.mzalendo.com/api/v0.1/hansard/entries/1104086/?format=api",
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"type": "speech",
"speaker_name": "Endebess, JP",
"speaker_title": "Hon. (Dr.) Robert Pukose",
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"legal_name": "Robert Pukose",
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"content": "Hon. Deputy Speaker, with specific categories in as far as how the KFDA contribute to the Big Four Agenda… I have talked about the universal healthcare which is important. I have talked about economies in terms of business, medicines, medical devices and biological products. It might be too technical when we talk about biological products, but I know some Members will understand. In medicine, we talk about therapeutic, meaning products that can treat. They have to be safe. They have to perform the intended function and are produced using appropriate standards and the benefits to human health associated with their use are favourably balanced against the risk of harm from the use of such products. We also have veterinary medical products which should also be safe, efficacious and of good quality. They are used in a manner that promotes human and animal health goals. This Bill will affect the governance and institutional arrangements in that it is intended to strengthen the Pharmacy and Poisons Board to become a regulatory authority. The development of the KFDA Bill has moved in tandem with the ongoing regional integration, particularly within the East African Community (EAC). One of the successful ventures is the harmonisation of the regulatory agreements within the EAC which was done as an EAC scientific directive on establishment of FDAs by member States. What is the current status? Currently, within the EAC countries, countries like Uganda, Rwanda and Tanzania have what we call regulatory authorities. It is only in Kenya that we are lagging behind. Therefore, it is important for us to be able to adopt this so that we can move as a country. The rationale for the proposed integration of the regulation of food and drugs is anchored on the tenets of science, particularly toxicology, that is, all chemicals and biological substances are potentially poisonous to humans whether in their natural state and under normal conditions of use or when prepared, used or applied inappropriately. Such chemical or biological substances can enter the human body through food, animal or plant origin, whether raw or cooked, processed or unprocessed; or medicines and medical products of all forms, including human vaccines and human blood for transfusing; or medical devices and products used to diagnose disease; or cosmetic products; or through veterinary medicines when administered to food-producing animals or through various chemicals used in agriculture, industrial or mining applications. Under Articles 43 and 46 of the Constitution, every person is guaranteed the right to the highest attainable standard of health and the right to be free from hunger and to have adequate food of acceptable quality and the protection of their health, safety and economic interests, respectively. The responsibility to ensure that food and drugs are safe for human consumption is, therefore, that of both the national Government and the county governments. This is based on the fact that while the national Government has the general responsibility to develop policies on health, agriculture and veterinary sciences, the county governments have the obligation to implement such policies. The Health Act No. 21 of 2017 is the overarching legislation providing for the regulation of healthcare services, healthcare service providers, healthcare products and health technologies. Section 62 of the Health Act recommends for the establishment of a single regulatory body for health products and technologies. The single regulatory framework contemplated under Section 62 of the Health Act has assigned the functions to, inter alia, licensed health products and health technologies, licensed manufacturers and distributers of health products, conduct laboratory testing and inspection of manufacturing, storage and distribution facilities of health products and The electronic version of the Official Hansard Report is for information purposesonly. A certified version of this Report can be obtained from the Hansard Editor."
}